FDA Hits LEO Pharma with Complete Response Letter Over Eczema Drug
The FDA has issued a complete response letter (CRL) to LEO Pharma, requesting additional information regarding a device component for the Danish drugmaker’s moderate-to-severe atopic dermatitis candidate tralokinumab.
The company made clear that the agency did not request any additional data on the clinical efficacy or safety of the drug, an anti-IL-13 monoclonal antibody that is administered subcutaneously.
LEO’s biologics license application for tralokinumab is supported by efficacy and safety data from three phase 3 trials that included more than 1,900 adults, according to the company. The drugmaker, whose pipeline focuses on skin disease treatments, is seeking the FDA’s approval for tralokinumab as a treatment for adults with moderate-to-severe atopic dermatitis.
The agency accepted its application in July 2020 and at that time set an action date in the second quarter of this year. It’s not known what impact the CRL could have on the timing of the FDA’s decision.